Ruling undercuts the FDA's regulation of supplements

Federal judge says agency went too far in banning ephedra

April 15, 2005|By Julie Bell | Julie Bell,SUN STAFF

A U.S. District judge has ruled that the Food and Drug Administration went too far by banning all products that contain the dietary supplement ephedra.

The ruling, signed Wednesday by Judge Tena Campbell in Utah, undercut the FDA's latest foray into regulating dietary supplements - products containing natural ingredients classified under the law as more like food than drugs.

Although the court provided what experts said was a clear rebuke to the agency, the immediate effect is likely to be minimal. The ruling allows the marketing of only low-dose ephedra products manufactured by plaintiff Nutraceutical International Corp., of Park City, Utah. Other manufacturers, however, might consider marketing low-dose ephedra products.

"The FDA interprets this to mean that the order remains in effect as to higher doses of these products and that it applies to the plaintiffs' products," FDA spokeswoman Kim Rawlings said. "FDA is considering all its options with respect to the next step it will take."

The company said yesterday that it hadn't decided whether to once again market Solaray, a product that contained a daily dose of 10 milligrams or less of ephedrine alkaloids. But Nutraceutical President Bruce Hough said the product accounted for a tiny amount of the company's $141 million in annual revenue in the fiscal year ended Sept. 30 and wasn't the point of the suit.

"What brought the suit was the FDA decided to create a new standard for making such a ban," Hough said. "That standard ... would mean we probably couldn't buy potato chips on the open market."

The FDA put the ban in effect a year ago, responding to a maelstrom of attention that followed the death in 2003 of Steve Bechler, a Baltimore Orioles pitching prospect. Bechler, who was taking ephedra for weight loss, collapsed and died of heatstroke during spring training. The natural stimulant constricts the blood vessels, speeds up the heart and can raise body temperature.

Mike Flanagan, the Orioles' vice president of baseball operations, said he was unsure of the ruling's implications. But, he said, "If the ban is lifted, I would be shocked and saddened."

The FDA said last year that it had received 3,000 reports of adverse health events related to ephedra. Public Citizen's Health Research Group has said 155 ephedra users have died over the years, a number Hough disputed.

Also known as Ma huang, ephedra is derived from the ephedra sinica plant. Its active ingredient is ephedrine, which the FDA regulates as a drug when it is synthetically made. Consumers bought millions of doses per year before the April 12, 2004, ban, responding to claims that it aided in weight loss, and enhanced athletic performance and energy.

The ephedra ban constituted the FDA's first attempt to employ a 1994 law giving the agency the authority to ban supplements that present "an unreasonable risk of illness or injury."

The agency banned ephedra because it said the risks to public health outweighed the benefits, the same standard it uses to determine whether to approve a drug. It is not clear whether the FDA will appeal.

"I hope and expect that FDA's ban will be upheld on appeal," said Rep. Henry A. Waxman, a California Democrat, in a statement. "If it is not, it will clearly be time for Congress [to] give FDA the authority it needs to protect American consumers from dangerous supplements."

Campbell's ruling remanded the issue "to the FDA for further rulemaking."

Martin J. Hahn, an attorney with the Washington offices of Hogan & Hartson, said that, while the ruling "obviously is a defeat for the agency," he expects the FDA to appeal.

"It provides an opportunity, I think, for companies who want to enter this arena," Hahn said. But, he added, businesses who try to jump into the market face "potentially a huge risk" that an appeals court will overturn Campbell's decision or that new FDA rules might have the practical effect of banning ephedra products.

Frank Palumbo, executive director of the University of Maryland's Center for Drugs and Public Policy, said of the ruling: "I think it's very important because it makes it much more difficult for the FDA to remove or ban a dietary supplement."

Sun staff writers Gail Gibson and Roch Kubatko contributed to this article.

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